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Online Resumes with "CMDCAS"



Regulatory Affairs Specialist

I Seek a fulltime Regulatory Affairs professional position that will utilize the achievements, skills, strategic thinking and leadership abilities that enable me to aid the company in timely submission packets; Wereby we consistently exceed earnings potentials and achieve company goals in any of today's global economic markets.

Tags for this Online Resume: Regulatory Affairs Professional, FDA 510(k), PMA, IDE, ICH, CE Markings, EU MDD, CMDCAS

Featured Profile

Quality Professional

Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...

Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis